Applying KISS to FSMA Rule Application

Departments - Produce Production

When an inspector walks into an off-farm packinghouse, it should be evident which FSMA rule the inspector needs to assess compliance against: Preventive Controls or Produce Safety. As it stands today, however, a simple determination isn’t possible.

The inspector would need to first dig out documents pertaining to the ownership of the packinghouse. Then the inspector would need to determine the source of all the produce packed (for the past year ... or three years? we’re not sure) to determine the percentage of the produce packed which originated from the farm(s) that own the packinghouse. In the case of a packinghouse owned by a co-op, this could be a lot of legwork. But it is only after the inspector gets a handle on this ownership issue that he or she can determine if the operation falls under the Preventive Controls or Produce Safety rule.

There has to be a better way. There is.

If an operation is simply packaging, packing or holding fresh produce that is a raw agricultural commodity (RAC):

If the product is not substantially transformed (e.g., it’s an apple going in and an apple going out), it should fall under the Produce Safety Rule.

If it’s transformed (e.g., a sliced apple going out) it should be under Preventive Controls.

Jim Gorny PMA Vice President, Food Safety & Technology

Does this impact the safety of the product? No. The Preventive Controls rule includes updated Good Manufacturing Practices. While not termed as such, the Produce Safety rule has nearly identical requirements scattered throughout the various subparts of the rule. FDA recognized the parity between the rules by allowing facilities conducting “off-farm packaging, packing and holding of raw agricultural commodities that are produce” to demonstrate compliance with GMPs by following either rule.

Some could argue that the Produce Safety rule is more stringent in terms of food safety requirements because microbiological hazards are assumed to be there — unlike in Preventive Controls, where Preventive Controls Qualified Individuals (PCQIs) can use judgment in the evaluation of whether a hazard requires a preventive control. The Produce Safety rule also has very prescriptive requirements around wash-water testing that are absent in Preventive Controls.

So, why is there confusion in the off-farm packinghouse issue that also affects cooling operations, warehousing/storage, etc.? Because Congress instructed FDA that the Preventive Controls rule would apply to facilities. This required FDA to re-evaluate the definition of “facility” which took us down a rabbit hole. FDA’s attempts to address the issue, while well intended, further complicated definitions resulting in increased confusion.

FDA has done a great job listening to produce industry concerns, however many produce businesses find the revised “farm” definition so convoluted and unclear that it is impossible to understand which rule applies to their operations and implement it with confidence. This inability to easily understand if a produce business meets the FDA definition of “farm”— and hence determine which FSMA rule they fall under — has created fear and anxiety of regulatory jeopardy in the produce community.

Last summer FDA published draft guidance intended to clarify when specific activities do and do not fall within the FDA definition of “farm.” The mere need for this guidance illustrates the complexity of the current “farm” definition. The draft guidance did not address what is meant by “under one management” and ‘”in one general (but not necessarily contiguous) physical location.” FDA noted its intent to help produce businesses figure out what rule they fall under on a case-by-case basis. Given the extraordinarily large number of firms involved, this approach is simply unworkable for businesses and overly burdensome for FDA.

In comments to the draft guidance, United Fresh Produce Association and the Produce Marketing Association (PMA), along with other produce associations, encouraged the agency to consider a proposal that foods that meet the definition of “produce” and “raw agricultural commodities” that remain the same product in commerce during postharvest handling be subject to coverage by the Produce Safety rule, irrespective of where they are grown, harvested, packed or held. This common-sense approach means that if a whole tomato remains a whole tomato when it goes through a packinghouse operation, the operation would be covered by the Produce Safety rule, irrespective of where that occurs. If that whole tomato is sliced or diced into a fresh-cut product, it has been substantially changed, meaning it is a different item because of processing, and it would be subject to the Preventive Controls for Human Foods rule.

This clear distinction between the coverage of the Produce Safety and Preventive Controls rules would strengthen enforcement and reduce confusion both for the produce industry and regulators. It also would provide uniform and effective regulation of all postharvest activities, irrespective of where they take place.

Congress allowed, in FSMA, an exemption from the Preventive Controls rule for facilities covered under the Produce Safety rule. Our interpretation is that we don’t need to be hamstrung in trying to define “farm,” since the Produce Safety rule can apply to produce whether in a farm or in a registered facility. In the comments, we also expressed our readiness to work with FDA and Congress, if need be, on a solution if it stems from how the FSMA statute was written. Let’s Keep It Simple.

24 Ways to Exclude Entry of Flying Insects

Features - Pest Management

From mosquitoes and moths to ladybugs, wasps, beetles, and multiple types of flies, there are more than 300 flying insects that threaten food facilities which rely on highly consistent sanitation for compliance with regulatory standards, said Mars Air Systems Vice President of Foodservice Sales & Corporate Marketing Julie Konowitz.

Although the emphasis is often placed on flies, “mosquitoes and night-flying moths are more common intruders than common house flies,” said Gardner Manufacturing General Manager Bruce Studer. “Exterior lighting is the primary attractant to the facility.”

Brandenburg Technical Manager Arthur Dales agreed, citing the example of a food production facility that runs 24 hours a day and has an employee entrance with a few concrete steps and an exterior light next to the door for safety. “Night-flying insects will be attracted to the doorway after dark and easily enter the structure with employees,” he said.

Additionally, decaying debris in trash cans, drains and cracks and crevices can attract fruit flies, phorid flies, common house flies and bottle flies; standing water can bring mosquito infestations; and fall invaders, such as stinkbugs or Asian ladybeetles, may enter a facility in large numbers. Although these seasonal pests are seeking a place to overwinter and are not attracted to food or breeding sites, they can cause problems if they get into food production areas.

FLYING INSECT ATTRACTANTS. Odors and heat, along with trash, decaying food, scum, and debris will attract flying insects to food-processing facilities. In addition, said VM Products Representative John Brownlee, many facilities have aging infrastructures, such as old sewer lines in need of repair, that create breeding sites for flying insects.

“Insects, like all lower-order creatures, are driven by three things: food, shelter and procreation,” said Paraclipse President and CEO R. Brad Harse. “They are not flying around actively thinking about how to get into this or that facility.”

Thus, in addition to food odors and trash, the flying insects are drawn to light, both for heat and warmth (i.e., shelter), and the natural instinct to procreate. So, the presence of pheromones, from others of their species or an artificially placed attractant, also will draw them.

Areas with food waste or other organic material can be very attractive to filth flies, said Syngenta PPM Technical Services Manager Nicky Gallagher. Blow flies, in particular, are strongly attracted to odors of raw or cooked meat, poultry, or fish. Dumpsters typically provide an ideal food source and breeding site for filth flies.

In fact, filth flies will seek out wet decaying organic material for breeding and will follow both odor and moisture trails. Because all food processing creates some waste, it is almost always this that attracts filth flies, Dales said. “However, there are food production processes that rely on controlled decomposition of food — cheese making, baking, and brewing are obvious examples — where the filth flies have no way to distinguish between what we consider food and they consider a potential breeding site.”

Small flies are often thought of as simply nuisance pests, but all flies can carry pathogens.

FLYING INSECT ENTRY POINTS. Once attracted to a facility, flying insects will enter through open doors, unscreened vents, and other gaps through which attractants are emitted. “Openings in general — to include doors and windows without any type of a barrier to protect the opening — allow for free entry of flying insects,” Konowitz said.

“Besides open dock doors, the most common entry points in food-processing facilities are the roof vents that emit odors,” Studer added.

Brownlee has seen several facilities with issues such as missing or damaged door sweeps, lack of air curtains and gaps around bay doors that allow flying insects to enter, he said. “However, one of the biggest culprits I have noticed is doors being left open while bringing in stock, taking out garbage, and employees simply entering and exiting a facility.” And dumpsters and trash cans often are so close to the facility that simply leaving a door open for a few seconds allows flying insects to enter.

Although the point of entry for flying insects is usually the same as that used for personnel and materials, Dales said, “Floor channels for wastewater will often lead out of structures via less obvious means, and may provide a ‘hidden’ pathway for filth fly entry.”

Other areas that may allow flies to enter are dumpster chutes with poor sealants, weep holes, and wall voids. And small flies, such as fruit flies, could be breeding in ripe and fermenting fruits and vegetables, Gallagher added.

“Insects can enter when carried on or in deliveries of supplies and in pre-adult forms that can then hatch and develop in the ‘safer’ interior confines of a facility,” Harse said. “They also enter facilities when present in bulk materials that are brought into a facility for processing, as eggs, larvae, or adults.”

Then, once inside, flying insects can get into the food production area in search of food or simply a place to rest. “Many food-processing facilities operate continuously and do not allow for proper sanitation and cleaning. Deep cleaning is difficult or impossible due to the operational hours of many food-processing facilities,” Brownlee said. This not only attracts flying insects but can provide food, harborage, and breeding areas.

“The ingredients and materials used in the process are natural attractants,” Konowitz said. “Sugar, oils, and any number of other attractants can harbor the insect as well as the reproduction of its offspring, thus causing a serious food safety concern.”

EXCLUDING FLYING INSECTS. Given the various flying insects that are attracted to food-processing facilities, the many attractants that bring them to entry points, the array of entry points through which they can get in, and the problems they cause once inside, what can be done for prevention?

Following are 24 recommendations on practical applications of integrated pest management principles from the previously cited experts:

Install fast-open screening, and maintain a positive air pressure to deter flying insects from entering.

Cover roof vents that emit odors with fine mesh.

Screen windows and doors as applicable, opening doors only when necessary.

Use air curtains to protect entry points that are used frequently. The curtain ejects a stream of air across an opening to inhibit entry of flying insects, dirt, dust and fumes, while allowing for easy entry and exit of people. Air curtains can be particularly helpful for facilities which have workflow requiring that main doors or larger roll-up and dock doors be opened repeatedly or remain open for a period of time to allow workers and people-transporting equipment to pass through safely.

Power down lights when not needed.

Eliminate excessive moisture and areas of standing water.

Use fly bait inside a secured fly-bait station to kill flies outside before they have a chance to enter. These can be particularly effective around dumpsters and near doorways. Some baits can be used inside a facility if secured inside a fly-bait station.

Replace door sweeps and seals around loading docks when worn, and manage the times when doors and entryways are open.

Use sanitation products that eliminate breeding sites to keep flies from reproducing if they do get inside. Microbial products break down the fats, oils, and grease and eliminate odors that can attract flies and provide harborage for egg-laying.

Use lures to monitor flying insect activity by placing them on sticky traps.

Remove lights that are next to doors or other openings. Instead, add a spotlight on a lamp post some distance from the door but directed toward it. This will provide the illumination needed for the employees, but will draw night-flying insects away from the door, reducing their potential for entry.

Separate wastes and their handling from high-traffic entrances and provide as much distance between sensitive (and fly-attracting) production areas and external entrances as possible and practical.

Place bottle/bag traps outdoors. Containing a liquid attractant, this bottle or bag system physically traps flying insects to reduce populations. They can be used indoors and outdoors, and are particularly effective near waste storage areas and along fence lines.

Install insect light traps (ILTs) between entry points and sensitive areas to intercept flying insects before they can proceed further. The light traps should be positioned away from direct sunlight and preferably in areas with a shadowed or darker background.

Because the ILTs literally attract the flying insects, don’t place them close to the areas you are trying to protect. Position them in line-of-sight but some distance away to draw the flying insects away from the area.

Add other forms of insect traps, such as sticky cards/ribbons and pheromone-laced lures, as applicable. When effectively placed (both indoors and outdoors) they can be useful for monitoring or reduction of adult insects.

Similarly, because trash bins attract pests, store these away from the building and entry ways.

Regularly clean all critical areas, including recycling containers, floor drains, or any other area that can hold water and food waste for prolonged periods of time.

Scatter granular fly baits around dumpsters or use in bait stations placed near entry points to intercept potential invaders.

Inspect incoming shipments that could transport fly eggs and larvae prior to bringing them into the facility.

Ensure your upstream supply chain has controls in place. Infestations can develop in your facility from the hatching of moth eggs which were present in purchased bulk materials.

Educate employees on the importance of communicating any insect problem they see as soon as possible. Honest communication from facility personnel regarding new infestation sightings or re-infestations is imperative for swift resolution.

Work with your pest control technician; control of flies requires cooperation and correction of any exclusion and sanitation problems.

THE LAST WORD. Although people often think that small flies, such as fruit flies, are simply nuisance pests, Brownlee said, “All flies can carry pathogens that can contaminate food.”

“One of the largest barriers to control of pest flies is human acceptance,” said Dales, who cited a survey asking respondents which pest, when sighted, would prevent them from finishing a meal: a cockroach, rat, or fly. “Not surprisingly, almost all responded the rat or cockroach,” he said. “We see a fly buzzing around our food and just shoo it away. Yet most respected health officials consider filth flies to be a significant health threat. If a rat is seen during a food production shift it will probably result in immediate attention; similarly, with cockroaches. A fly however, well — not so likely.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.

Does GFSI Certification Equate to FSMA Compliance?

Departments - Legislative Update

Ever since the rules of the Food Safety Modernization Act (FSMA) began being published, the industry has questioned its linkage with the Global Food Safety Initiative (GFSI) certification. As such, a major question has been: “If I am certified to a GFSI scheme, does that mean I will also be compliant with the rules of FSMA?” The short answer has long been: “You are likely close, but not necessarily completely compliant.” But now, certification to the newly released GFSI Benchmarking Requirements V7 should move food facilities even closer.

FSMA RULE DEVELOPMENT. In the development of the rules for FSMA, FDA reviewed and took into consideration numerous inputs and documents, including the requirements of GFSI along with those of other programs — domestic and international; input from public meetings; proposed-rule comments; etc. At the 2012 Global Food Safety Conference, then-Deputy Commissioner for Foods Michael Taylor said, “As we build our new import system, we want to work closely with GFSI and build on the foundation you have established for effective and credible certification programs.” And with a majority of public meeting participants expressing interest in “seeing or participating in the creation of comparative analyses of existing programs, plans, and schemes (such as GFSI) to provide industry with a better understanding of what, specifically, they need to do in order to comply with FSMA and FSVP requirements,” FDA had little choice but to at least consider these programs.

The agency is continuing to consider stakeholder input in its implementation of the rules. For example, FDA scheduled a February public hearing specifically to request input on strategic partnerships it should consider to enhance the safety of imported food. Recognizing the importance of strengthening existing collaborations among food safety regulators, the agency said the public hearing provided an opportunity for it to “receive input from stakeholders as it develops, expands, and refines partnership activities related to imported foods.” Of even greater relevance to this topic, a key focus of the hearing was to obtain information on the role of partnerships “to enhance risk-based decision making through the consideration of private standards, the recognition of commodity-specific export programs, and the implementation of the existing systems recognition program.”

While this public hearing focused specifically on imported foods, I would see any alignment with GFSI as crossing over to all the rules of FSMA. I say this because of FDA’s statement that “while the FSMA regulations are not the subject of this public hearing, the initiatives that will be discussed align with and support FSMA implementation.”

So, if the safety standards are to be the same, I would expect that consideration or recognition of a standard (i.e., GFSI) for an imported food would mean consideration or recognition of the standard for a food produced in the U.S. as well.

What makes all this of even greater relevance is that, with its release of it Benchmarking Standards version 7 (previously titled GFSI Guidance Document), GFSI is bringing its requirements into closer alliance with FSMA — adding new requirements for food defense and food fraud prevention into all GFSI scopes; incorporating a requirement for unannounced audits; and expanding the supply chain approach to include food brokers and agents.

FDA field inspectors prepare samples of imported seafood for laboratory analysis. THE FSMA/GFSI LINKAGE. So, while that is all good information, it doesn’t really address the base question of whether or how far GFSI certification ensures FSMA compliance. But I addressed exactly that at a recent briefing in Washington, D.C., at which I showed that, in a comparative analysis, GFSI V7 generally meets or exceeds all the requirements in the FSMA preventive controls rule — with GFSI actually exceeding FSMA in some cases where it has requirements not reflected in FSMA.

At the same meeting, GFSI Chair Mike Robach noted GFSI as being an example of a partnership being able to achieve something that no company could do alone, that is, achieving “massive reciprocity on a global scale.”

This reflects GFSI’s central aim of “once certified, accepted everywhere,” and is the very goal that I see FDA as seeking (or should be if it isn’t), as it is what will enable FSMA to be accepted globally, and not seen as a trade barrier.

All that said, a food facility that is GFSI certified cannot expect that this automatically makes it FSMA compliant. While there are areas in which the facility will exceed FSMA requirements, there are definite differences between the two, and there are requirements of FSMA that are not a part of GFSI, such as having a Preventive Controls Qualified Individual, specific Produce Safety water requirements, etc. But, despite the differences, being GFSI certified will take you a long way down the road to FSMA compliance, essentially just leaving some FSMA-specific details for enhancement.

It is the new GFSI V7 requirements that truly lessen the differences between the two. While the most obvious of these may be the added focus on food defense and food fraud, what I see as being of even greater consequence is the new requirement for unannounced audits. FDA doesn’t tell you when an inspector is going to show up at your door, and now, neither will you always know when a GFSI scheme auditor will appear. While it may seem to be a negative for food facilities who like to ensure they are prepared for such audits, it actually will reflect as a positive, not only ensuring that you maintain the standards on a daily basis, but also enabling you to feel more secure that your food safety program is at full implementation when the unannounced FDA inspector does arrive at your door.

So, while the answer to the question with which I began this column remains: “With GFSI certification, you are likely close, but not necessarily completely compliant, with FSMA,” I’d now add: If you are GFSI V7 certified, you are definitely in a good place.

If you’re not, consider taking your facility through the process. Not only will it move you down the road to FSMA compliance, it will help you analyze and improve your food safety program to protect your consumers and your brand.

Validation of Control Points for Low-Moisture Foods

GMA Off The Shelf - GMA Off The Shelf

Several disease-causing microorganisms can survive in low-moisture foods and have been implicated in food recalls in recent years. Organisms, such as Salmonella in ready-to-eat foods and snacks, and E. coli and Listeria in dehydrated meats, can pose the potential for illness to consumers. Thus, it is the responsibility of the food producer to provide safe food by preventing pathogen presence or destroying those that have the potential to be present.

Low-moisture foods present some challenges. Pathogenic organisms exhibit greater resistance to heat in low-moisture foods than in moist foods. For example, while Salmonella can be destroyed in a moist food in a short time at temperatures of 160°F, the Guidelines for Validation of Dry Roasting Processes from the Almond Board of California states that Salmonella destruction in almonds takes more than 1.5 hours at 250°F.

Two vitally important components are needed to document process control for processors of low-moisture foods: (1) scientific data that states the required processing limits to achieve pathogen destruction; and (2) in-plant measurements to show the limits are met. The scientific data is part of the design phase of the HACCP/Food Safety Plan. The in-plant data is part of execution. Those two elements are at the heart of the validation and verification requirements of FDA and USDA.

Each of these may be used to justify a food safety measure in a HACCP or Food Safety plan. But low-moisture food procesors may face the challenge of little scientific or technical data for their products. If that is the case, then a challenge or inoculated-pack study may be required. In such a study, a product is subjected to a treatment — such as a heat treatment or addition of an ingredient that inhibits the targeted microorganisms. After the treatment, the product is tested to see if the microorganisms have been reduced or eliminated. The final report from the study can be used to justify the safety of the food, when properly processed, and will describe the in-plant processing parameters used to control the microorganisms of concern for the product.

Let’s consider how a study could be conducted for beef jerky (USDA regulated) or a meat-containing pet treat (FDA regulated) produced in different facilities. Assume that each product has formulation control for beginning moisture, protein, fat content, and possibly the addition of preservatives. Ending moisture is specified.

For such a product, the design phase begins with a hazard analysis, including:

Assemble the HACCP/Food Safety Plan team, with food safety experts.

Describe the product.

Identify its intended use.

Construct a process flow diagram.

Conduct on-site confirmation of the flow diagram.

List potential hazards of each step.

Conduct an analysis of hazard severity.

Consider any measures to control identified hazards.

Imagine that each of the two products is processed in a drying oven, and that heat will be used to destroy the pathogens of concern. Oven time, temperature, and air flow settings are known.

So, how do we conduct the study? Perhaps in a microbiology laboratory, perhaps in the processing plant with a harmless surrogate microorganism. A useful article describing considerations for such a study, “Parameters for Determining Inoculated Pack/Challenge Study Protocols” by the National Advisory Committee on Microbiological Criteria for Foods, outlines aspects of study design, selection of experts to assist with studies, microbiological testing, and writing of a final report. Your report should explain the critical processing steps or conditions that are necessary to assure pathogen destruction or inhibition. Critical conditions could include process times, temperatures, humidity, pH, concentrations of ingredients or treatments, or other items relevant to the product and process.

More on Low-Moisture Foods

GMA is holding its Science Forum April 18-21 at the Capital Hilton in Washington, D.C. A pre-forum workshop, Pathogens in Low-Moisture Foods: Control and Validation Strategies, will be conducted on the morning of April 18. It will focus on:

Pathogens of concern in low-moisture products and their sources.

Regulatory requirements.

Best industry practices for control of low-moisture food pathogens.

Validation of heat processed low moisture foods.

THE EXECUTION PHASE. Data from the production plant is used to demonstrate that the process parameters can be consistently delivered using the specific equipment in the plant. This requires acquisition of facility data and confirmation that all the scientific parameters from the design phase are met. Both FDA and USDA’s Food Safety Inspection Service (FSIS) require that control points be validated in-plant.

FDA’s FSMA Preventive Control rules (21 CFR 117 for human food and 21 CFR 507 for animal feed) state that the first part of validation, the scientific justification, takes place prior to implementing a food safety plan, and the in-plant demonstration of capability should take place within 90 days of production start, or within another reasonable time frame as justified by the Preventive Controls Qualified Individual.

How is the in-plant work conducted for our example products? The FSIS Compliance Guideline for HACCP Systems Validation describes that plants should:

Implement the critical operational parameters in the production process consistent with the parameters in the scientific support;

Identify at least one product from each HACCP category for which to gather in-plant validation data;

Collect in-plant data demonstrating the effectiveness of the implementation of the critical operational parameters for at least one product from each HACCP category; and

Analyze the data to determine whether the critical operational parameters are being implemented effectively.

The report from the in-plant execution phase is kept with the scientific justification from the design phase. Reports are part of the food safety or HACCP plan. During the facility’s daily operation, in-process data is collected; operator observations of the process take place; and record review occurs, consistent with the design and execution requirements. When established limits are exceeded, corrective action occurs.

Validation is comprised of up-front design and in-plant execution for any food governed by FDA and USDA. Low-moisture foods can present special considerations beyond some other foods, due to the potential for increased microbial resistance to some treatments. With the scientific design and plant execution completed, food safety is maintained by adherence to defined process parameters.

The author is a senior science advisor, GMA, and contributing author of the forthcoming book, Control of Salmonella and Other Bacterial Pathogens in Low-Moisture Foods, edited by Richard Podolak and Darryl G. Black.

Enough Is Enough

Departments - From Our Readers

Editor’s Note: Having been “on both sides of the fence,” the author provides his insights on and recommendations for audits, particularly as related to pest management.

By Al St. Cyr

The pest management industry would appear to be entering into another age of countless opinions on how programs should be designed and implemented for food facilities. Unfortunately, these opinions are often coming from people with little or no expertise or practical experience. Hardly a week goes by that I do not get a call for advice on what a third-party individual is demanding be done at a food account. Far too often, the search for advice is not based on interpretation of an audit standard but solely on the opinion of an individual auditor. Unfortunately, not many customers will question the “opinion” of the auditor for fear of retribution.

A sad part of this is that people who audit or inspect facilities are supposed to subscribe to a code of ethics to follow the designated audit criteria or standard, and not deviate or inject their own personal biases. Having been an auditor, I admit this can be difficult at times, but that is what discipline is all about. It appears that the field of pest management has become a particular target for some individuals who lack knowledge and skills in pest management.

The true and respected professionals in our trade invested long hours to accumulate a vast knowledge of science-based, practical experience to improve their understanding of many industries. They have learned from their own and other people’s mistakes to try to make sure the failures are a teaching moment, not repeated. It is hard to pinpoint exactly when this acquired knowledge began being replaced by non-substantiated opinion.

THE SCIENCE OF PEST MANAGEMENT. What concerns me is that the pest management industry is coming under increasing pressure from groups that have absolutely no knowledge or understanding of the science of modern pest management. More concerning is their refusal to seek the counsel of recognized industry experts. Far too many times, I am baffled by where these groups acquired their information or how, exactly, they formulated their policy. How did totally non-related and anecdotal bits of information suddenly become linked together and expressed as fact?

Let me reference a few examples:

NPMA’s Pest Management Standards for Food Processing and Handling Facilities is a guidance document that should be used to meet the established criteria of audit schemes.

A state investigator recently cited a client, who was using pheromone traps to monitor for stored product pests, with improper storage of a pesticide leading to contamination of food products in the warehouse. It was said that since the pheromone was a volatile material, it was contaminating food products (in packaging) around each trap. This investigator insisted the traps be removed and the food items evaluated for disposal.

An auditor failed a facility for having placed mouse snap traps with a common commercial attractant in a warehouse rack system where a mouse had been reported as being seen. The auditor said the use of baits in a food facility was illegal (not so according to rodenticide labels) and the traps would only work if they were placed along the wall. The facility’s request for review was denied.

According to another auditor, FSMA requires that a facility have copies of the résumés for the pest control company owner, branch manager, immediate supervisor, and technician working in the facility. Their reasoning is that we need to prove every person involved in the pest control program proves his or her competence. A statement was made by the auditor that pest management is now a preventive control under FSMA rather than a prerequisite program. I fail to see what a résumé has to do with proof of competency or understanding of the job. I would have thought the state-issued license, NPMA QualityPro certificate, and NPMA GMP exam certificates would have sufficed. Nope, new rule with this auditor is résumés. (By the way, IPM is a prerequisite program.)

Patio blocks can no longer be used to secure the stations because someone can pick it up, take it home, break into it, and get the bait. They have to be bolted to the building or staked to the ground. Past experience tells me that these are the two least favorable options. The industry secured the bait inside the station to prevent children and animals from shaking out the bait. When attached to a foundation, the stations will just get higher and higher as the ground around the plant sinks. As one facility manager said, “I just spent $450,000 to pour concrete around my facility, and now you are telling me I have to let you drill holes every 50 feet?” Yup. The auditor told me I had to.

Every bait station has to have a “Poison” label on it because everything used in them is poisonous. Apparently, this person is not familiar with non-toxic monitoring blocks that are an integral part of a proactive preventive monitoring program, and is a system commonly used for organic and LEED facilities. PR Notice 94-7 simply requires a station be capable of displaying a “Precautionary Statement.” Some states have rules about identifying the rodenticide contained in the station but not all. These stations were labeled as “Toxic Bait” or “Non-Toxic Monitor” to reflect what is in them. But that was not good enough for this auditor: Label all as poison regardless of what is in it.

This one stopped me dead in my tracks: An auditor said, “You have to have the bait stations directly on the ground against the wall so the rats can find the hole in them because rats are blind. Up on patio blocks they will never find them.”

If you are having a BRC audit, all of your equipment must conform to British rules and regulations because the BRC is a British audit. The bottom line is that the auditor simply did not like the particular bait station the company was using. It was fully compliant with EPA requirements and each was appropriately installed.

Everyone has his or her own nightmare stories about the sad requirements some people have tried to place on pest control in food plants, but having to build a platform at each side of a third-story roll-up door used once a year during deep maintenance, so that bait stations could be installed at each side of every exterior door of a facility, kind of topped them all.

ENOUGH IS ENOUGH. Pest management and food safety professionals: say enough is enough. Read and learn the criteria being used to inspect/audit your facility. When auditors are clearly injecting their personal opinions on an issue, demand they show cause in the audit criteria. If it does not make sense to you, question the validity of what they are telling you to do. Show me the science or regulation please.

I recall a time when inspectors were chosen from a field of people who had a track record of success and an ability to teach. It was an honor to be asked to join the ranks of a recognized organization with a history of success helping companies grow and succeed. Even though many of the audit schemes specify the number of years a person must have in a given industry before he or she can officially audit a firm in that category, it would appear that, today, a piece of paper stating so will do.

Many competent pest control companies spend considerable resources of money and time to train their technicians to work in the food industry. We maintain licenses as required by the states we work in and must maintain continuing education to retain them. How many auditors can say the same? The reality is that, in the state of California and others, you have to have a license to legally identify pests and make recommendations for a control strategy. The sad truth is that very few auditors have invested in learning science-based pest management and acquiring the credentials permitting them to do so.

Like the food industry, the pest management industry is far from without fault. Both industries need someone looking over their shoulders to help keep things on track. During recent years, there has been a significant loss of common knowledge about pest management strategies and what is needed in a food plant. This seems to have fostered a sense of animosity rather than cooperation.

There are many dedicated and informed auditors practicing their trade. Many of them also scratch their heads at some of the edicts coming down from the armchair experts. Collectively there needs to be an open forum to discuss ideas and concerns. Priorities are the concerns for the safety of the consumer and the integrity of the food products. Keep this in mind and use a little common sense, and we should all be fine. The one who has the most number of devices in the end is NOT the winner. The one with a well-thought-out, risk-based program free of any pest activity is.

I would strongly suggest the audit groups and their entire staff acquire a copy of the National Pest Management Standards for Food Processing and Handling Facilities . This document outlines accepted approaches for pest management in any food handling establishment. It is a guidance document that should be used to meet the established criteria of an audit scheme rather than simply using the opinion of an ill-informed auditor who may change his mind frequently.

The author, who is President of ASC Consulting, was formerly with a food industry auditing organization.